MucoLock™ for Treatment of Stomatitis

Recruiting now · Not applicable

Conditions studied: Stomatitis, Pain, Burning Mouth, Burning Mouth Syndrome, Oral Dysesthesia

In brief

The purpose of this research is to test how well people can tolerate MucoLock™ as a treatment for mouth pain or burning sensation and how well it works to reduce mouth pain or burning sensation. Study participants will be asked to use MucoLock™ topical solution as a "swish and spit" solution (similar to mouthwash) three times per day for 5 minutes each time, for 28 days.

Key facts

Study ID

NCT07506018

Run by

Baptist Health South Florida

People needed

25

Starts

2026-07-16

Expected to finish

2028-08-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older
• Individuals with oral dysesthesia (worst VAS sensitivity/burning score ≥ 7 over the last week)
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Inability to comply with study instructions
• Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements*
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
• Advanced kidney disease
• Patients receiving antineoplastic therapy [e.g., tyrosine kinase inhibitors (TKIs), radiation] that could increase the risk of oral dysesthesia
• Known altered mental status, encephalopathy, or cognition impairment
• Ataxia
• Known alcohol use disorder
• Concomitant opioid therapy
• Diagnosis of oral cancer currently undergoing therapy
• Already using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)*
• Any opioid pain medication*
• Treatment with another investigational drug or other intervention within 2 weeks. Patients will be recommended to stop previous medication for 2 weeks before starting the study treatment.
• (asterisk) *Modifiable criteria, with a timeframe of 2 weeks for a washout period.

Where it is running

• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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